MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-15 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[139168786]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139168787]
It was reported that the support arm of the ventilator broke. The patient involvement is unknown. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2019-00176 |
| MDR Report Key | 8425309 |
| Date Received | 2019-03-15 |
| Date of Report | 2019-09-16 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Manufacturer G1 | MAGNUS LINDQVIST |
| Manufacturer Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUPPORT ARM 177 |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2019-03-15 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | ROENTGENVAGEN 2 SOLNA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2019-03-15 | |
| 1 | 0 | 2019-03-15 |